Cleared Special

K150389 - Spiral Flow Peripheral Vascular Graft

K150389 is an FDA 510(k) clearance for Spiral Flow Peripheral Vascular Graft, manufactured by Vascular Flow Technologies, Ltd.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Special 510(k) pathway after a 77-day FDA review.

K150389 · Vascular Flow Technologies, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
77d
Days
Class 2
Risk

K150389 is an FDA 510(k) clearance for the Spiral Flow Peripheral Vascular Graft. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Vascular Flow Technologies, Ltd. (Dundee, GB). The FDA issued a Cleared decision on May 6, 2015 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150389

510(k) Number K150389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date May 06, 2015
Days to Decision 77 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 181
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K150389.
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
K162803 · Vascutek, Ltd. · Jul 2017
Gelweave Vascular Grafts
K162794 · Vascutek, Ltd. · Jun 2017
FUSION Vascular Graft
K153523 · Maquet Cardiovascular, LLC · Feb 2016
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
K142062 · Vascular Flow Technologies, Ltd. · Nov 2014
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
K141124 · Vascular Flow Technologies, Ltd. · May 2014
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
K131778 · Maquet Cardiovascular, LLC · Nov 2013
K150389 · Spiral Flow Peripheral Vascular Graft
Download PDF FDA Summary Vascular Flow Technol…